Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126709581 | 12670958 | 1 | I | 20160327 | 20160329 | 20160822 | 20160822 | PER | US-JAZZ-2016-US-006026 | JAZZ | 46.20 | YR | F | Y | 0.00000 | 20160822 | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126709581 | 12670958 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126709581 | 12670958 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126709581 | 12670958 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126709581 | 12670958 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126709581 | 12670958 | 5 | C | FIBERCON | CALCIUM POLYCARBOPHIL | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 6 | C | SUCRALFATE. | SUCRALFATE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 7 | C | BISOPROLOL FUMARATE. | BISOPROLOL FUMARATE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 8 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 9 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 11 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 12 | C | RHINOCORT | BUDESONIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 13 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 14 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 15 | C | ASACOL | MESALAMINE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 16 | C | KARIVA | DESOGESTRELETHINYL ESTRADIOL | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 17 | C | Doxepin | DOXEPIN | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 18 | C | HYOSCYAMINE. | HYOSCYAMINE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 19 | C | KEFLEX | CEPHALEXIN | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 20 | C | Nortriptyline hcl | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 21 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 22 | C | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 23 | C | CLARINEX | DESLORATADINE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 24 | C | Calcium | CALCIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 25 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 26 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 27 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 28 | C | MIRCETTE | DESOGESTRELETHINYL ESTRADIOL | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 29 | C | Natalcare | 2 | U | 0 | ||||||||||||
| 126709581 | 12670958 | 30 | C | Potassium | POTASSIUM | 1 | U | 0 | |||||||||||
| 126709581 | 12670958 | 31 | C | PROVIGIL | MODAFINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126709581 | 12670958 | 1 | Narcolepsy |
| 126709581 | 12670958 | 4 | Ill-defined disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126709581 | 12670958 | Drug ineffective | |
| 126709581 | 12670958 | Feeling abnormal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126709581 | 12670958 | 1 | 200712 | 200802 | 0 | |
| 126709581 | 12670958 | 3 | 201509 | 0 |